There have been only a few precedential decisions from the Federal Circuit related to obviousness since spring sprung. While these decisions have produced mixed results for the lower courts, clinical study protocols have held...more
Janssen Pharms., Inc. et al. v. Teva Pharm. USA, Inc. et al., Appeal Nos. 2022-1258, -1307 (Fed. Cir. April 1, 2024) In this week’s Case of the Week, the Federal Circuit vacated-in-part a district court’s bench trial...more
On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed...more
On May 5, 2020, Manson J. of the Federal Court issued the second decision on the merits under the amended Patented Medicines (Notice of Compliance Regulations). The Court upheld the validity of Janssen’s patent for...more
As previously reported, the Federal Court of Appeal (FCA) dismissed Millennium Pharmaceuticals and Janssen’s appeal from a decision granting Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of...more
As previously reported, the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of Compliance) Regulations relating to Teva’s bortezomib product (Janssen markets bortezomib as...more
Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more
In 2018 we reported on a number of developments in life sciences IP and regulatory law. Our most-read articles were: #1 a June update on biosimilars (authored by Urszula Wojtyra); #2 a “live” summary chart of Vanessa’s Law...more
On July 18, 2018, Justice Locke of the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for losses suffered while market...more
No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding - What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC)...more
On February 8, 2018, the Federal Court of Appeal issued public reasons for its decision dismissing Teva’s appeal relating to the damages and costs awarded against it for its infringement of Janssen’s patent for levofloxacin...more
Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more
About the PTAB Life Sciences Report: Each month we will report on recent developments at the PTAB involving life sciences patents. Argentum Pharmaceuticals LLC. v. Janssen Oncology, Inc. - PTAB Petition: ...more